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NCT Number: NCT06371729

DEEP Substrate Mapping Versus Activation Mapping for VT

Substrate-based DEEP mapping and activation mapping are two of the main techniques used for guiding ventricular tachycardia (VT) ablation. There is no data comparing directly the extent of applicability, procedural results, and the long-term outcomes between the two mapping strategies.This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence.

The primary endpoint of the study is to compare recurrence-free survival rate of ventricular tachycardia at 12 months and procedural feasibility of substrate-based DEEP mapping versus activation mapping for VT ablation.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital

Milan, Lombardy, 20132, Italy

Location status: Recruiting

Location contact

Andrea Radinovic, MD

CONTACT

Paolo Della Bella, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with an implanted ICD (all brands)
  • Patients with the indication for Ventricular Tachycardia Ablation (both first and redo procedures), supported by EnSite 3D mapping system, for the following disease aetiologies: previous MI, myocarditis, arrhythmogenic right/left ventricular dysplasia
  • Age: 18 years or more.
  • A participant is willing and able to give informed consent for participation in the trial and is available to respect the assessments described in the protocol and informed consent form.

Exclusion criteria

  • Contraindication to anticoagulants.
  • Presence of thrombi.
  • Presence of Mitral and Aortic prosthetic valve.
  • Recent (less than 3 months) myocardial infarction, unstable angina, or Coronary Artery Bypass.
  • Ventricular Tachycardia caused by reversible pathology.
  • Life expectancy less than 1 year, according to the investigator.
  • Contraindications to the use of ablation/diagnostic catheters or to cardiac catheterization.
  • Female participant who is pregnant, lactating, or planning pregnancy during the course of the trial.

Treatment and study plan

DEEP mapping

Procedure

The Substrate-based DEEP Mapping aims to identify the arrhythmogenic substrate of VT in sinus rhythm (SR). A standardized VT mapping and ablation procedure in SR has been proven effective in reducing VT recurrences in a multicenter setting by targeting late potential (LP) abolition. Regions with LPs and LAVAs that displayed decremental behavior evoked during right ventricular (RV) pacing with extra stimuli (decrement-evoked potential; DEEP), colocalized with the regions of the initiation and diastolic pathway of the VT more accurately than those areas displaying non decremental LPs.

Device use for mapping and ablation procedure:

FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN)

Activation Mapping

Procedure

VT Activation Mapping can localize reentry circuits, and the diastolic pathway isthmus is the desirable target for ablation when possible because it can eliminate the elements required for reentry. In fact, activation mapping of the entire diastolic pathway is associated with higher freedom from VT recurrences compared to substrate modification

Device use for mapping and ablation procedure:

FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN)

Primary outcomes

  1. VT recurrence free survival rate

    Time frame: after 12 months from the procedure

    Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences

  2. Procedural feasibility

    Time frame: During the index procedure

    Percentage of patients in which the mapping strategy was achievable and reasons for failure.

Secondary outcomes

  1. Procedural data.

    Time frame: During the index procedure

    Procedure duration (minutes)

  2. Hemodynamic VT tolerance

    Time frame: During the index procedure

    Hemodynamic decompensation during the procedure. (Arterial blood pressure <80 mmHg)

  3. Clinical follow up data.

    Time frame: after 12 months from the procedure

    • Number of ICD shocks at follow-up
    • Rate of subsequent hospitalizations for VT recurrence/HF
    • Cardiac mortality.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Radinovic, MD

CONTACT

[email protected]

+390226436316

Anna Montagna, PhD

CONTACT

[email protected]

+390226437489

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Registry information

Official study title

Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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